For many years, the treatments developed to treat the chronic and rare conditions that people in our communities live with each day have succeeded because of those who have been willing to participate in clinical trials.
As too many African-American families know all too well, Sickle Cell Disease (SCD) is a very painful, chronic genetic disease that can affect every organ in the body. While, in a normal body, blood cells are round and can move through the body easily, howbeit, patients with sickle disease develop cells that are malformed into a “sickle” shape and can be hard and sticky. They cannot move as easily and get stuck in blood vessels causing immense pain. In addition, the sickle-shaped cells die off faster, creating a deficit of red blood cells, resulting in anemia.
Although there have been breakthroughs in finding life-saving treatments for sickle-cell anemia in Colorado and across the country; we need to greatly step up efforts to overcome decades of understandable fear and skepticism within the African American community about medical research, and help move progress forward. It’s a healthcare crisis in our backyard that we can solve.
This debilitating and life-shortening disease affects more than 100,000 people in the U.S., mostly African-Americans. Life expectancy is 48 years for females and 42 years for males with Sickle Cell Anemia.
For many decades, we in the African-American healthcare community have been battling SCD and its effects. Progress in finding treatments has been extremely slow and frustrating for our patients. However, as we see increased hope, we are also shining a spotlight on the challenges that researchers are grappling with as they seek solutions.
First, the good news. The federal Food and Drug Administration (FDA) recently approved the first new drug for treating SCD complications – the first such approval in two decades. In fact, it’s only the second approval overall.
Many new drugs are in the development stage. Any drug that is brought to market has undergone extensive clinical trials, and success of those trials requires the participation of patients. Trials for SCD treatments are no exception.
Yet one of the biggest challenges in our community is convincing patients to enroll in clinical trials. For decades, there has been a deep mistrust and even fear of the medical community among African Americans, tracing back to tragic and cruel experiments conducted in the last century. That memory has left a deep scar in the black psyche. That fear has taken a toll in the ability to make progress against SCD. Recent reports show that nearly one-third of existing SCD clinical trials had to be terminated early due to the lack of participants. This creates significant delays in the ability to gain approval of potential new treatments for the disease.
Groups such as the Colorado Council of Black Nurses, Inc. and Colorado Sickle Cell Association, Inc. along with many others in the African-American community have been urging sickle-cell patients to talk to their providers about participating in clinical trials. We spend a great deal of time, explaining to every patient the safety and security inherent in these trials, as well as the great service that they can provide for the sickle-cell community worldwide.
It is very difficult to make headway. We need much more focused efforts from within the research and medical community. We know the massive expenditures of time and treasure these innovators invest in bringing a medicine to the clinical trial phase and we’re ready to partner with drug developers, the public health community, elected leaders and others to step up advocacy for patients and their families.
It’s not sufficient to just throw up our hands because patients aren’t coming through the doors. We must understand the deep-seated and emotional reasons why African-Americans are apprehensive and then work collectively, aggressively and collaboratively to calm those fears and create a safe and welcoming path to participation in clinical trials. It is absolutely essential – and long overdue — for African Americans to be included in these clinical trials.
In addition to the lives at stake in Colorado and around the country, SCD exerts a massive cost on the American healthcare system, with estimates that each patient costs nearly $1 million in treatment by age 45. And for those patients who rely on emergency room visits to seek treatment, that cost is sharply higher.
It’s time to unite in the fight against a disease that, while rare, has had a devastating effect on African-American families. We know that breakthroughs are on the horizon and without an effort to greatly expand the number of patients stepping up to join clinical trials those life-extending innovations will remain, sadly, out of reach.
# # #
Margie Bell-Cook, Ph.D., RN is Professor Emeritus of Health Professions retired from Metropolitan State College in Denver and is a board member of the Eastern Colorado Council of Black Nurses, (Inc Colorado Chapter of the National Black Nurses Association).